Tissue perforation device and method

ABSTRACT

A tissue perforation device and method. The device preferably includes a housing having a housing pass-through, a penetrator securely and sealably positioned so that the penetrator device passes through the housing pass-through, and a vacuum system comprising a vacuum source securely and sealably attached through the housing for advancing a patient&#39;s tissue onto the penetrator device.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to a tissue perforation device andmethod. More particularly, the present invention relates to a device,which draws skin and underlying tissue onto a perforation device andaway from vulnerable underlying structures.

[0003] 2. Background of the Invention

[0004] Significant morbidity and mortality occurs each year byiatrogenic injuries during establishment of pneumoperitoneum prior tolaparoscopic surgical procedures. The main source of these injuries isinadvertent perforation of blood vessels or organ structures within theabdominal cavity when the penetration device (needle, trocar or punchbiopsy cutting tool) is advanced too far through the abdominal wallpiercing the underlying organs that are located adjacent thereto. Theseinjuries are more common with inexperienced surgeons, but can occur evenin the most experienced hands. Built-in safety devices exist in theperforation devices themselves, but injuries still occur because of theclose proximity of the structures that are intended to be perforated andthose to be avoided.

[0005] Vacuum has been used to fix or distort the body and bodycavities. In addition, techniques exist for insufflation, or mechanicalor vacuum elevation of the abdominal wall during surgical procedures.

[0006] In U.S. Pat. No. 6,042,539, a vacuum-actuated tissue-liftingdevice and method for performing a surgical procedure in an operativespace of a patient are disclosed. The preferred device has a shell witha profile configured to surround a tissue surface of the patient, avacuum port located on the shell for applying a vacuum between the shelland the tissue surface, and an air conduit extending through the shellto permit air to pass into the operative space of the patient whenvacuum is applied.

[0007] In U.S. Pat. No. 6, 340,358, a trocar is disclosed having asafety shield control mechanism that prevents the inner cannula fromrotating and from moving axially when in the locked position. The safetyshield control mechanism applies consistent pressure on the safetyshield and has an open architecture for ease of sterilization. Thetrocar provides holding levels for different sizes of hands.

[0008] In U.S. Pat. No. 6,197,041, a pneumatically powered trocarassembly is disclosed that includes a source of compressed gas whichreleases a metered amount of gas to a chamber. A piston slidablypositioned within the chamber is driven forward by the compressed gasintroduced therein, and an obturator with a tissue piercing tip areadvanced thereby. Optionally, a sensor detects the presence of bodytissue within the cutting path of the tip and blocks the passage ofcompressed gas to the chamber, or alternatively, opens an escape vent torelease compressed gas therefrom if insufficient body tissue resistanceis encountered.

[0009] In U.S. Pat. No. 5,669,883, a Veress needle and cannula assemblyis disclosed that includes a stainless steel cannula assembly with acannula having an outer diameter of approximately 4 mm and a Veressneedle assembly having a Veress needle with an outer diameter ofapproximately 3 mm. The cannula assembly includes a proximal valveassembly and the Veress needle is insertable through the valve assembly.

[0010] In U.S. Pat. No. 5,690,607, an apparatus is disclosed forallowing two retractors to be used to lift the abdominal wall to provideimproved visualization and working space in the abdomen of obesepatients, and in the lateral regions of the abdomen of normal patients.The apparatus connects a first retractor and a second retractor to amechanical lifting arm, and comprises a bar, and first, second, andthird connecting devices. The apparatus is used by making a firstincision and a second incision in the abdominal wall at separatedlocations. The first retractor is inserted into the first incision, andthe second retractor is inserted into the second incision. The firstretractor and the second retractor are attached to the crossbar, anal alifting force is applied to the crossbar.

[0011] In U.S. Pat. No. 5,575,759, an apparatus for retracting an organto gain access to treat a tissue is disclosed. The apparatus has a mainenvelope, a second envelope, a first inflation device and a secondinflation device. The main envelope encloses a main chamber, andincludes a window and a removable window. The second envelope coverssubstantially all the main envelope, except the window and the removablewindow. The second envelope and the main envelope enclose a secondchamber outside the main chamber. The first inflation device passes afluid into the main chamber to expand the main chamber and the secondchamber from a compacted state to retract the organ. The secondinflation device passes a fluid into the second chamber to furtherexpand the second chamber to maintain the organ in its retracted stateafter fluid has been released from the main chamber.

[0012] In U.S. Pat. No. 5,562,603, an apparatus is described forlaparoscopically retracting an organ inside the body to provide surgicalaccess to adjacent tissue. The apparatus includes a thin, flexibleenvelope, which encloses a chamber. The envelope is laparoscopicallyinsertable in a collapsed state into a body cavity, and the chamber isinflatable to an expanded state following introduction of the envelopeinto the body. Inflation of the chamber causes retraction of adjacenttissue. An elastomeric seal is insertable into the chamber followinginflation and is attachable to part of the envelope inside the chamberfollowing inflation of the chamber. The seal provides a gas-tight sealto maintain the chamber in the expanded state, and to maintain the organin the retracted state, notwithstanding the piercing of an aperture inthe part of the envelope covered by the seal.

[0013] In U.S. Pat. No. 5,531,856, an inflatable apparatus for organretraction includes a main envelope that forms a main chamber isdisclosed. An additional chamber is formed by attaching the periphery ofan additional envelope to the outside or the inside of the mainenvelope. The part of the surface of the main envelope that is notcovered by the additional envelope provides a plurality of windows,which, after the additional chamber is inflated, may be at leastpartially removed to provide apertures through, which treatment orobservation can be carried out.

[0014] In U.S. Pat. No. 5,527,264, a method is disclosed for retractingan organ inside the body to provide access for treating a tissue, aretractor having a main envelope, which defines a main chamber ispositioned in a collapsed state adjacent to the organ to be retracted.The main chamber is subsequently inflated to retract the adjacent organ.A surgical instrument is passed through the main envelope into the mainchamber to contact the tissue for treatment. In U.S. Pat. No. 5,522,790,a first inflatable retraction device is disclosed having a firstinflatable chamber and a non-pressurized chamber inside the mainchamber. The non-pressurized chamber is expanded by inflating a secondinflatable chamber. The non-pressurized chamber enables the main chamberto remain inflated when an aperture is cut in the envelope of the mainchamber, through which treatment is carried out. A second inflatableretraction device has an inflatable retractor and a maintainer. Theinflatable retractor retracts the organ and the maintainer maintains theorgan in its retracted condition after the inflatable retractor isdeflated. The maintainer can be inflatable, and can be inside or outsidethe inflatable retractor. A self-retracting endoscope has an opticalassembly with an expandable retractor fitted to its distal end. Thedistal end of the endoscope is inserted into the body with the retractorin a collapsed condition. The retractor is then expanded to retractorgans that would otherwise obstruct the view from the distal end of theoptical assembly. After observations are complete, the retractor isreturned to its collapsed condition. An insertion tube enablescylindrical objects, such as packaged inflatable retraction devices, tobe pulled, instead of pushed, into the body. The additional chamber ofan inflatable retraction device having two inflatable chambers is filledwith a slurry of a particulate solid in a liquid. The liquid is removedand the additional chamber evacuated to consolidate the particulatesolid. This increases the retracting strength of the additional chamber.

[0015] In U.S. Pat. No. 5,505,689, a fan retractor is disclosed forlaparoscopic surgery has a pair of angle-shaped elements with first legsdisposed in parallel relationship to one another and second legsextending laterally from the first legs for movement between ajuxtaposed collapsed condition and a fanned-out expanded conditionresponsive to rotation of the first legs about their longitudinal axes.Actuators are provided on the first legs to move the second legs betweenthe collapsed and extended conditions. A first lock engages theactuators to lock the second legs in the extended condition and againstmovement toward or away from one another. A second lock in the form of ablock slidably received on the first legs is selectively engageablebetween the second legs when in the extended condition. When engaged,the second lock serves both to block the second legs from movementtoward one another and to restrain the first legs against movement awayfrom one another.

[0016] In U.S. Pat. No. 5,465,711, an organ or tissue plane to beretracted is performed to gain access for a surgical instrument to treatan organ or tissue plane to be treated. An inflatable retractor,including a main envelope enclosing a main chamber, is provided with themain envelope in a collapsed state. The main envelope of the retractoris placed adjacent the organ or tissue plane to be retracted. The mainchamber is inflated to an expanded state to retract the organ or tissueplane to be retracted. An aperture is pierced in the main envelope toprovide access for the surgical instrument passed into the main chamberto contact an organ or tissue plane to be treated while the main chamberis maintained in the expanded state, notwithstanding the aperturepierced in the main envelope.

[0017] In U.S. Pat. No. 5,454,367, an inflatable retractor including amain envelope enclosing a main chamber is provided. The main envelope isprovided in a collapsed state. An elastomeric window is also provided.The main envelope of the inflatable retractor is placed adjacent theorgan inside the body, and the main chamber is expanded to an expandedstate to retract the organ. Following inflation of the main chamber tothe expanded state, the elastomeric window is attached to the mainenvelope inside the main chamber to cover part of the main envelope. Thesurgical instrument is passed into the main chamber. An aperture ispierced in the pan of the main envelope covered by the elastomericwindow to provide access for the surgical instrument to contact thetissue. The elastomeric window provides a gas-tight seal to maintain themain chamber in the expanded state.

[0018] In contrast to known techniques and methods, the preferred deviceof the present invention advances tissue to be perforated onto astationary perforation device and away from the underlying structures.The simplicity of technique leads to a short learning curve andvirtually eliminates the possibility of iatrogenic injuries

SUMMARY OF THE INVENTION

[0019] The preferred embodiment of the invention advances tissue to beperforated onto a perforation device or piercing instrument. Presently,the primary intended use of the preferred embodiment is for pulling theabdominal wall onto a perforation device, such as a Veress needle,trocar or punch biopsy cutting tool, and away from abdominal viscera andgreat vessels for the initial establishment of pneumoperiotoneum.Another intended application for the preferred embodiment is forimplanting a device below the skin surface for diagnostic or therapeuticpurposes. The present invention is not limited to these applications andmay be extended into other diagnostic and therapeutic applications.

[0020] The limitations imposed on the invention are expressly set out inthe appended claims only. The invention itself, however, both as to itsconstruction and its method of operation, together with additionalobjects and advantages thereof, will be best understood from thefollowing description of the specific embodiments when read andunderstood in connection with the accompanying drawings.

LIST OF REFERENCE NUMERALS UTILIZED IN THE DRAWINGS

[0021]10—tissue perforation and inflation device (10)

[0022]12—housing (12)

[0023]12A—housing seal (12A)

[0024]12C—housing pass-through (12C)

[0025]14—penetrator (14)

[0026]14A—penetrator tube (14A)

[0027]14B—penetrator valve (14B)

[0028]14C—penetrator device (14C)

[0029]14D—penetrator tube (14D)

[0030]16—vacuum system (16)

[0031]16A—vacuum tube (16A)

[0032]16B—vacuum valve (16B)

[0033]18—abdominal wall (18)

[0034]18A—abdominal wall bubble (18A)

[0035]20—top center housing (20)

[0036]22—O-ring (22)

[0037]24—optical device or camera (24)

[0038]30—“clamshell” housing (30)

[0039]32—collar or adapter plate (32)

[0040]34—left half section (34) of housing (30)

[0041]36—right half section (36) of housing (30)

[0042]38—eft sealing edge (38)

[0043]40—right sealing edge (40)

[0044]42—left half seal (42)

[0045]44—right half seal (44)

[0046]46—“clamshell” housing pass-through (46)

[0047]50 bell housing (50)

[0048]52—opening (52)

[0049]54—bell housing pass-through (54)

BRIEF DESCRIPTION OF THE DRAWINGS

[0050]FIG. 1 is a side view of a tissue perforation device (10)positioned over a non-extended abdominal wall (18).

[0051]FIG. 2 is a bottom view of the perforation device (10).

[0052]FIG. 3 is a side view of the perforation device (10) exhibiting anextended abdominal wall (18) forming an abdominal wall bubble (18A).

[0053]FIG. 4 is an exploded perspective view of a “clamshell” housing(30).

[0054]FIG. 4A is a view of the clamshell housing (30) being removedafter penetration with penetration device (14C).

[0055]FIG. 5 is a side view of a bell housing (50).

[0056]FIG. 5A is a perspective view of the bell housing (50) beingremoved after penetration with penetration device (14C).

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0057] The following is a detailed description of the preferredembodiment of the invention.

[0058] Referring to FIG. 1 and FIG. 2, which are a side and bottom view,respectively, of a perforation device (10) positioned over anon-extended abdominal wall (18). The device (10) comprises a housing(12) having a housing pass-through (12C) and a housing seal (12A) alonga perimeter functioning to form a tight seal between the housing (12)and an abdominal wall (18). The housing (12) is manufactured from astrong non-collapsible material to withstand the internal negativepressure in the range of about 50 to 250 mm Hg exerted therein. Suitablematerials are specifically designed for medical use and capable ofsterilization. The materials include plastic, plastic composite, rubber,rubber composite, fiberglass, epoxy, glass, glass composite, and thelike. Plastic, such as polycarbonate, and plastic composites areparticularly well suited due to its superior strength, transparency,rapid manufacturing and low cost. The housing (12) is usuallytranslucent or transparent. Transparency is preferable to allow thephysician to monitor the perforation. Housing (12) is sized toaccommodate adults and children of different sizes and/or body massindexes. The diameter of the circumference of housing (12) in contactwith the abdomen for adults ranges from about 3 inches to 8 inches andfor pediatric patients from 1½ to 3 inches.

[0059] A penetrator (14) is securely and sealably positioned through atop center housing (20) of the housing (12). The seal and fixation ofthe penetrator (14) can be done by means of the 0-ring (22). The sealand fixation of the penetrator (14) can also be accomplished by othermeans, e.g., by pressing the operator's fingers on penetrator (14) andbraced against the housing pass-through (12C). The penetrator (14)comprises a penetrator device (14C), such as a Veress needle, trocar, orother suitable device, designed to penetrate or cut tissue. Thepenetrator (14) has a valve (14B) for allowing the penetrator tube (14D)either to introduce ambient room air, or for connection to a pressurizedsource of a gas, e.g., carbon dioxide, helium, nitrogen, air andmixtures thereof, for insufflation. The tissue perforation device (10)further comprises a standard operating room vacuum system (16). A vacuumtube (16A) is securely and sealably attached to the housing (12) througha valve or pressure regulator (16B), which functions to regulate theamount of negative pressure exerted within the housing (12).

[0060] Referring now to FIG. 3, an extended abdominal wall (18) is shownwith an abdominal wall bubble (18A). In the preferred embodiment,abdominal wall bubble (18A) is formed by applying negative pressure atvacuum tube (16A), which extends into and is sealed against housing(12). Internal negative pressure within the housing (12) creates anabdominal wall bubble (18A) within the housing (10) and elevates theabdominal wall (18) away from the underlying organs and vascularstructures. As the abdominal wall bubble (18A) enlarges, the abdominalwall (18) is advanced onto the stationary penetrator device (14C). Roomair or inert gas introduced through penetrator valve (14B) into theperitoneal cavity to further facilitates the separation between theabdominal wall (18) and the underlying organs and vessels. Preferably,the penetrator device (14C) contains an optical device or integralcamera (24) at its tip to direct visualization of the passage ofpenetrator device (14C) through tissue.

[0061] The distance of tissue movement is controlled directly by theoperator through regulation of the vacuum. This may be controlled byperiodic opening of a vacuum valve, or through a regulator (16B).Optimal vacuum will be a function of the tissue characteristics, andwill be regulated by the operator to achieve the desired tissuedisplacement.

[0062] Following penetration and insufflation, the applied vacuum may bereleased and the housing (12) removed by means of a “clamshell” housing(30) shown in FIGS. 4 and 4A or by means of an adaptor plate or collar(32) shown in FIG. 5 while leaving the perforation device (14C) in placethrough the abdominal wall (18).

[0063] Referring now to Figures FIGS. 4 and 4A, a perspective view of“clamshell” housing (30) is shown, which is another embodiment of thehousing (12) shown in FIGS. 1-3. In this embodiment, the housing (30)comprises left half section (34) and right half section (36) having maleleft sealing edge (38) and female right sealing edge (40), respectively,which cooperate to form a tight seal when vacuum is applied to housing(30). Left half seal (42) and right half seal (44) are respectivelymolded in the top of left half (34) and right half (36) of housing (30)forming pass-through (46) in housing (30) that is sized to accommodatevarious sizes of penetrator tubes (14A).

[0064]FIG. 4A shows housing (30) being removed after the abdominal wall(18) has been penetrated with the penetrator device (14C) and the vacuumhas been released to leave penetrator (14) in place without itsdisturbance.

[0065]FIGS. 5 and 5A shows another alternative embodiment of housing(12). In this embodiment, a perspective view of a bell housing (50)having opening (52) to accommodate the adaptor plate or collar (32) isshown. In this embodiment, a needle or trocar is sealed withinpass-through (54) in an adapter plate or collar (32), which is sealinglymounted in opening (52) of housing (50). Adapter plate (32) has a ¼ turnbayonet or thread on its edge. When the surgeon makes a ¼ (90 degrees)turn of the penetrator (14), adapter plate (32) is released from opening(52).

[0066]FIG. 5A shows the bell housing (50) being removed after theabdominal wall (18) has been penetrated with the penetrator (14C), thevacuum has been released, and the penetrator (14) has been rotated toleave both the adaptor plate (32) and penetrator (14) in place.

[0067] As this device may be adapted to work with any current or futurecommercially available trocar or Veress needle devices simply bychanging the size of the pass-through (54) in the adaptor plate (32 ),the techniques for establishment of pneumoperitoneum, and the testingfor adequate penetration past the peritoneum will be device dependantand are not described herein as they are well known to those skilled inthe medical arts.

EXAMPLE

[0068] This example illustrates the embodiment of the present inventionshown in FIGS. 1-3 in which housing (12) was a Tupperware®) bowl havingO-ring (22) inserted in the center of the bottom of the bowl. Theexample is for illustrative purposes only and are not meant to limit thescope of the claims in any way.

[0069] In experimentation with a post mortem female pig, a standardhospital 300 mm Hg vacuum source was used to elevate the externalabdominal surface 2-4 inches, depending on the amount of vacuum appliedby vacuum system (16). The stationary Veress needle (14C) penetrated thepig's abdomen without difficulty and water was observed to drain uponpenetration. CO₂ was attached and the abdomen insufflated to 12 mm Hg.Following insufflation, a 10 mm Ethicon Endo-Surgery trocar wasinstalled at the midline 1″ caudal to the xiphoid and a 30° Stortzcamera (24) was inserted to verify uninjured tissue below the needleentry site, and to observe the inside abdominal wall. The experimentalneedle was removed and the experiment repeated at 2 mm Hg insufflationunder direct observation from inside the abdomen. After externalapplication of vacuum, from inside the abdomen, the abdominal wall couldbe seen arching up and away from the internal contents, and the needletip was seen penetrating the displaced tissue.

[0070] It will be understood that each of the elements described above,or two or more together, may also find a useful application in othertypes of constructions differing from the type described above. Anexample of another application of the apparatus of the present inventionis the performance of a surface skin biopsy where the stationarypenetrator (14) is designed to only penetrate a certain distance intotissue of the abdominal wall (18).

[0071] While the invention has been illustrated and described asembodied in an abdomen perforation and inflation device, it is notintended to be limited to the details shown, since it will be understoodthat various omissions, modifications, substitutions and changes in theforms and details of the device illustrated and in its operation can bemade by those skilled in the art without departing in any way from thespirit of the present invention. What is claimed as new and desired tobe protected by Letters Patent is set forth in the appended claims.

What is claimed is:
 1. A tissue perforation device comprising: a housinghaving a housing pass-through; a penetrator securely and sealablypositioned so that the penetrator device passes through the housingpass-through; and a vacuum system comprising a vacuum source securelyand sealably attached through the housing for advancing a patient'stissue onto the penetrator device.
 2. The tissue perforation device asdescribed in claim 1, wherein the penetrator device is selected from agroup consisting of a needle and a trocar.
 3. The tissue perforationdevice as described in claim 2, wherein the penetrator device is a punchbiopsy cutting tool.
 4. The tissue perforation device as described inclaim 1, wherein the housing comprises a housing seal along theperimeter.
 5. The tissue perforation device as described in claim 1,wherein the housing is manufactured from a strong non-collapsiblematerial.
 6. The tissue perforation device as described in claim 1,wherein the vacuum system is controlled by a vacuum valve or regulator.7. The tissue perforation device as described in claim 1, wherein thepenetrator is securely and sealably positioned by means of theoperator's fingers braced against the pass-through in the housing. 8.The tissue perforation device as described in claim 5, wherein thematerial is selected from a group consisting of plastic, plasticcomposite, rubber, rubber composite, fiberglass, epoxy, glass, and glasscomposite.
 9. The tissue perforation device as described in claim 8,wherein the housing the material is translucent or transparent.
 10. Thetissue perforation device as described in claim 1, wherein thepenetrator further comprises a penetrator valve sealably connected tothe penetrator tube.
 11. A tissue perforation device comprising: ahousing comprising a translucent or transparent material selected from agroup consisting of plastic, plastic composite, rubber, rubbercomposite, fiberglass, epoxy, glass, and glass composite and having ahousing pass-through; a penetrator securely and sealably positionedthrough a top center of the housing, the penetrator comprising aninsufflation valve located outside the housing and sealably connected toa penetrator tube securely and sealably affixed to a penetrator devicelocated inside the housing; and a vacuum system comprises a vacuum valvesealably connected to a vacuum tube securely and sealably positionedthrough the housing for exerting a negative pressure on a tissue walland elevating the tissue onto the penetrator device.
 12. The tissueperforation device as described in claim 11, wherein the penetratordevice is selected from a group consisting of Veress needle and trocar.13. The tissue perforation device as described in claim 11, wherein thepenetrator device is a punch biopsy cutting tool.
 14. The tissueperforation device as described in claim 11, wherein the vacuum valve isa vacuum regulator.
 15. The tissue perforation device as described inclaim 11, wherein the housing is separable into at least two sections.16. The tissue perforation device as described in claim 15, wherein thehousing is separable into two half sections, each section having asealing edge to achieve a vacuum seal and a pass-through to receive thepenetrator device.
 17. The tissue perforation device as described inclaim 11, wherein the housing comprises a bell-shaped body having anopening, and an adapter plate having a pass-through to receive thepenetrator device.
 18. The tissue perforation device as described inclaim 17, wherein the adapter plate forms a vacuum seal with theopening.
 19. A method of establishing pneumoperitoneum comprising thefollowing steps: exerting negative pressure though a vacuum tube into ahousing forming a tight seal between the housing seal and an abdominalwall; forming an abdominal wall bubble within the housing by elevatingthe abdominal wall away from underlying organs and vascular structures;piercing the abdominal wall with a penetrator device; and allowing roomair to enter, or injecting inert gas, into the peritoneal space formedbetween the abdominal wall and the abdominal organs.
 20. The method ofpneumoperitoneum as described in claim 19, wherein the penetrator deviceis selected from a group consisting of needle and trocar.
 21. The methodof pneumoperitoneum as described in claim 19, wherein the penetratordevice is a punch biopsy cutting tool.
 22. The method ofpneumoperiotneum as described in claim 19, wherein the penetrator devicecontains an optical device or integral camera at the tip to allow directvisualization of the passage through tissue.
 23. The method ofpneumoperitoneum as described in claim 19, wherein the negative pressureis in the range of about 50 to 250 mm Hg.
 24. The method ofpneumoperitoneum as described in claim 19, wherein the inert gas isselected from the group consisting of carbon dioxide, helium, nitrogen,and mixtures thereof.
 25. The method of pneumoperitoneum as described inclaim 19, wherein the housing is separated into two sections afterpenetration by the penetrator device and the release of the negativepressure and is removed from the abdominal wall, and wherein thepenetrator device is left in place through the abdominal wall.
 26. Themethod of pneumoperitoneum as described in claim 19, wherein the housingcontaining an opening for an adapter plate having a pass-through for thepenetrator device is removed from the abdominal wall after penetrationby the penetrator device and the release of the negative pressure, andwherein the penetrator device is left in place through the abdominalwall.